Closing on: Oct 1, 2022

Job Description

The following is intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required.

Job Purpose
This position is responsible for carrying out quality responsibilities according to ISO and FDA requirements and will be required to participate as a team member in establishing, maintaining, and improving the quality system.

Duties and Responsibilities
The Quality Specialist will perform duties in support of the quality management system. Those duties include one or more of the following:

  • Maintain and submit information for GUDID.
  • Maintain information for training assignments in the Quality Management System (QMS), electronic and paper as applicable.
  • Evaluate and audit suppliers as part of the supplier management process, and maintain supplier records in the QMS. Facilitate supplier investigations of quality issues.
  • Initiate, evaluate, investigate and resolve customer feedback and complaints (CFCs). Document CFCs in the QMS. Submit reportable events to the respective regulatory agencies.
  • Perform internal audits and maintain the schedule and internal audit records in the QMS.
  • Coordinate and facilitate investigation activities, product impact, root cause analysis, corrections, and corrective & preventive action as part of the CAPA process in the QMS.
  • Assist in the preparation for and performance of regulatory inspections and external audits.
  • Assist the QA Director with managing and improving the quality system. Facilitate Management Review.
  • Train as a backup for any of the following duties: Document Control, and nonconformance management.
  • Other duties as assigned

Qualifications

  • Bachelor’s Degree in a technical field preferred
  • 2+ years experience in an FDA-regulated industry and/or Quality
  • Medical Device industry experience preferred
  • Communication and presentation skills
  • Detail-oriented and a self-starter.

Working Conditions

  • This position works in an open office environment. While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk and sit.
  • The position may require up to 20% travel

Physical Requirements

  • Requires standing/walking/sitting 30 percent of the time. Requires the ability to travel on aircraft, car, bus, boat, or common transportation means.
  • Requires use of hands and arms to operate computers, copy machines, and telephone.

Job Type: Full-time

Pay: $63,000.00 – $75,000.00 per hour

Benefits:

  • 401(k)
  • Dental Insurance
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Life insurance
  • Paid time off
  • Vision insurance

Schedule:

  • 8-hour shift
  • Monday to Friday

Education:

  • Bachelor’s (Preferred)

Experience:

  • FDA regulations/Quality: 2 years (Preferred)
  • Medical device industry: 1 year (Preferred)

Work Location: One location

Department: Quality Control
Position: Corporate Position
States: California
Job Location: Santa Clarita

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